NCT01265342

Brief Summary

Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy. The purpose of this study is to evaluate the efficacy of beclomethasone (administered by nebuliser twice a day) in preventing viral wheezing in pre-school children who had had episodes in the preceding 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

1.4 years

First QC Date

December 22, 2010

Last Update Submit

March 10, 2014

Conditions

Bronchial SpasmRespiratory SoundsRespiratory Tract Infections

Keywords

Bronchial SpasmRespiratory Tract InfectionsViral wheezingChild, PreschoolBeclomethasoneItalyPhysicians, Primary CarePediatrics

Outcome Measures

Primary Outcomes (1)

  • % of children with wheezing (diagnosed by the paediatrician) during the URTI episode.

Secondary Outcomes (12)

  • % of patients needing medical care during the treatment period;

  • % of patients receiving rescue medication during the treatment period;

  • % of patients admitted to an emergency department during the treatment period

  • Duration of the respiratory tract infection episode

  • % of patients with an asthma-like symptom score (rated by parents) >= 7

  • +7 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Beclomethasone

EXPERIMENTAL

Beclometasone suspension 400 mcg will be administered through a nebuliser twice a day, in the morning and in the evening, for 10 days

Drug: Beclomethasone

Interventions

BeclomethasoneDRUG

Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days

Beclomethasone
PlaceboDRUG

Placebo nebulised suspension twice a day for 10 days

Placebo

Eligibility Criteria

Age12 Months - 71 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Outpatient children 1-5 years old
  • Presence of any viral upper respiratory tract infection symptoms
  • At least one episode of viral wheezing (diagnosed by a physician) in the last 12 months.
  • No, or minimal, asthma-like symptoms in between separate airway infections

You may not qualify if:

  • Steroid hypersensitivity
  • Inhaled and/or oral corticosteroid use in the preceding month
  • Chronic respiratory disease (e.g. cystic fibrosis, broncho-pulmonary dysplasia)
  • Presence of wheezing at the entry visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

ASL NA/3 Sud

Castellammare di Stabia, Italy

Location

AUSL Chieti

Chieti, Italy

Location

ASL Monza Brianza

Monza, Italy

Location

ASL Torino 3

Pinerolo, Italy

Location

ASP di Reggio Calabria

Reggio Calabria, Italy

Location

Ausl Roma E

Roma, Italy

Location

AUSL Taranto

Taranto, Italy

Location

Azienda ULSS 20 Verona

Verona, Italy

Location

ASL 12

Viareggio, Italy

Location

Related Publications (1)

  • Clavenna A, Sequi M, Cartabia M, Fortinguerra F, Borghi M, Bonati M; ENBe Study Group. Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT. Pediatrics. 2014 Mar;133(3):e505-12. doi: 10.1542/peds.2013-2404. Epub 2014 Feb 17.

    PMID: 24534400RESULT

MeSH Terms

Conditions

Bronchial SpasmRespiratory SoundsRespiratory Tract Infections

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Antonio Clavenna, MD

    Mario Negri Institute for Pharmacological Research, Milan, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 23, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

October 1, 2012

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

IT(9)